Stage (next event)
December 1, 2020
Catalyst Info & Data Links
TITLE: HETLIOZ® (tasimelteon) for Smith-Magenis Syndrome (SMS) - PDUFA
ClinicalTrial.gov (NCT02776215) Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
ClinicalTrial.gov (NCT02231008) Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS
WHAT IS THE NEXT CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
2019: Tasimelteon Demonstrates Efficacy in Improving Sleep Disturbances of Individuals with Smith-Magenis Syndrome (SMS). Sleep, 42(Supplement_1), A255-A255.
MECHANISM OF ACTION / RATIONALE
The precise mechanism by which tasimelteon exerts its therapeutic effect in patients with Non- 24 is not known. Tasimelteon is an agonist at melatonin MT1 and MT2 receptors. These receptors are thought to be involved in the control of circadian rhythms (learn more pg 6).
Smith-Magenis syndrome affects at least 1 in 25,000 individuals worldwide.
Learn more - U.S. National Library of Medicine
Updated by HC
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